For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive…. ANDA 218797, held by Hikma. Sapropterin Dihydrochloride.
As of Nov 15, 2026, ANDA 218797 (Sapropterin Dihydrochloride), held by Hikma, was first approved by FDA on Jun 11, 2025, with 0 approved supplements and 0 published complete response letters.
Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe- restricted diet.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sapropterin Dihydrochloride100MG · tablet;oral | Sapropterin Dihydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
